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MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.

This study is ongoing, but not recruiting participants.
Information provided by Hoffmann-La Roche

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.
Official Title † A Study to Evaluate the Safety of MabThera (Rituximab) Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma Who Have Responded to Induction Therapy.
Brief Summary

This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.
Detailed Description
Study Phase Phase IV
Study Type † Interventional
Study Design † Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure † Incidence of all, and of grade 3/4, adverse events. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Secondary Outcome Measure † PFS, event free survival, overall survival, time to next lymphoma treatment, PR to CR conversion rate. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Condition † Non-Hodgkin's Lymphoma
Intervention † Drug: rituximab [MabThera/Rituxan]
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status † Active, not recruiting
Enrollment † 500
Start Date † September 2006
Completion Date March 2011
Eligibility Criteria †

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • histologically confirmed grade 1, 2 or 3a follicular non-Hodgkin's lymphoma;
  • patients who have received adequate (>=8 cycles) induction therapy with MabThera as first line treatment, or treatment for relapsed disease;
  • demonstrated partial or complete response to induction therapy.

Exclusion Criteria:

  • stable or progressive disease after most recent induction therapy;
  • transformation to high grade lymphoma;
  • patients with prior or concomitant malignancies, except non-melanoma skin cancer or adequately treated in situ cancer of the cervix.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Albania,   Argentina,   Australia,   Bosnia and Herzegovina,   Brazil,   Bulgaria,   Colombia,   Croatia,   Ecuador,   Egypt,   Finland,   Germany,   Greece,   Israel,   Italy,   Mexico,   Romania,   Russian Federation,   Slovakia,   Slovenia,   Spain,   Sweden,   Switzerland,   Turkey
Administrative Information Fields
NCT ID † NCT00430352
Organization ID MO19872
Secondary IDs ††
Study Sponsor † Hoffmann-La Roche
Collaborators ††
Investigators †
Study Director:     Clinical Trials     Hoffmann-La Roche, +1 973 235 5000    
Information Provided By Hoffmann-La Roche
Verification Date June 2008
First Received Date † January 31, 2007
Last Updated Date June 17, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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